Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion

Running, not enrolling · Phase 2

Conditions studied: Erythroplakia, Hyperplasia, Oral Cavity Carcinoma, Oral Leukoplakia

In brief

This phase IIa trial studies how well metformin hydrochloride works in preventing oral cancer in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia). Oral premalignant lesions look like red or whitish plaques or lesions in the mouth that do not rub off and can be associated with a higher risk of cancer. Metformin hydrochloride may help prevent oral cancer from forming in patients with an oral premalignant lesion.

Key facts

Study ID: NCT02581137
Run by: National Cancer Institute (NCI)
People needed: 26
Starts: 2016-06-10
Expected to finish: 2026-12-19
Last updated by the study team: 2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants with oral leukoplakia or erythroplakia with mild, moderate, or severe histologic dysplasia, or hyperplasia not associated with mechanical factors such as ill-fitted dentures
Measurable disease - minimum lesion size of 8 x 3 mm before initial biopsy
Karnofsky performance status >= 70%
Leukocytes >= 3,000/microliter
Absolute neutrophil count >= 1,000/microliter
Platelets >= 100,000/microliter
Total bilirubin =< 1.5 × institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =<1.5 × institutional ULN
eGFR > 40 mL/min using the Cockcroft-Gault equation
Life expectancy > 3 months
Willing to use adequate contraception (barrier method, abstinence, subject has had a vasectomy or partner is using effective birth control or is postmenopausal) for the duration of study participation
Ability to take oral medication
Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

Patients with diabetes who are taking insulin or oral agents
History of diabetic ketoacidosis
Participants may not be receiving any other investigational agents within past 3 months
History of allergic reactions attributed to compounds of similar chemical composition to metformin or prior use of metformin within the last year
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, human immunodeficiency virus (HIV)-positive, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Oral carcinoma in situ
History of chronic alcohol use or abuse defined as any one of the following: a) average consumption of 3 or more alcohol containing beverages daily in the past 12 months; b) consumption of 7 or more alcoholic beverages within a 24 hour (hr) period in the past 12 months
Glycated hemoglobin (HbA1c) > 8%
Pregnancy or nursing women
Acute or chronic liver disease, evidence of hepatitis (infectious or autoimmune), cirrhosis or portal hypertension
History of renal disease
History of prior head and neck squamous cell carcinoma (HNSCC) unless curatively treated for >= 1 year
Have received chemotherapy and/or radiation for any malignancy (excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment) in the past 2 years; ongoing adjuvant hormonal therapy for breast cancer is allowed

Where it is running

UC San Diego Medical Center - Hillcrest — San Diego, California, United States
University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
BC Cancer Research Centre — Vancouver, British Columbia, Canada
University of British Columbia Hospital — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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